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Micro-tumor Guided Cancer Therapy Selection MicroCaT

Periodic Reporting for period 2 - MicroCaT (Micro-tumor Guided Cancer Therapy Selection MicroCaT)

Reporting period: 2019-02-01 to 2020-01-31

"Colorectal cancer (CRC) is the second biggest cancer killer in Europe with an estimated number of 176,974 CRC death in a year. Once diagnosed with CRC, many patients receive chemotherapy that is based on standard protocols comprising combinations of several drugs. The effectiveness of each of these drugs has been established in clinical trials which have determined an average effect on a group of patients. However, just like every human is unique, so is each cancer patient’s tumor. A tumor’s sensitivity or resistance to therapy is very different from one person to the next. Drug therapies that work for one patient may not work for another, even if they carry the same diagnosis. This explains why most patients fail to show significant improvement in response to an initially chosen chemotherapy protocol. At the same time these patients suffer from unwanted side effects and after two months are switched to another drug regime – giving rise to additional drug and hospital costs.

The overall objective of the MicroCaT project is the clinical validation and commercialization of IndiTreat®, an ex-vivo chemosensitivity test developed by 2cureX A/S, a Danish SME. IndiTreat® is a functional precision medicine test using live 3D microtumors prepared directly from a patient’s tumor. These microtumors are exposed to a variety of different drugs, drug combinations and new targeted therapies and – put simply – IndiTreat® measures in real time which treatment causes the microtumors to die. It such allows the selection of the most effective and least toxic drug regimen for each individual patient prior to initiating treatment. For the oncologists and patients this greatly improves the probability of selecting an effective drug treatment.

In the field of cancer biology, it is now well established that cancer cells interact directly with their micro-environment. Within a tumor, cancer cells ""talk"" to each other and to all the surrounding cells including blood vessels, immune cells and connective tissue cells that all participate and contribute to the cancer process. The 3D microtumors used in IndiTreat® best reflect the situation of a patient’s tumor environment which is essential to accurately predict the clinical response of the individual patient. The expected outcome of MicroCaT is the clinical validation and market introduction of the CE-marked IndiTreat® test for pre-therapeutically measuring an individual CRC-patient’s response to different drug therapy options. Together with clinical study sites in Denmark, Germany and the UK, 2cureX conducts an interventional study with metastatic (stage IV) colorectal cancer patients and establishes both clinical evidence and utility of IndiTreat®. Communication and dissemination of MicroCaT project activities will be key to bring this breakthrough innovation to the attention of clinicians, patients and health assessment authorities. Commercializing IndiTreat® for CRC patients will enable 2cureX to significantly grow and expand its business."
The work performed during the first two years of the MicroCaT project centred around five main activities: First, to provide the basis for expanding the IndiTreat offering to Germany and the UK, 2cureX has established an operational 2CX Branch (100 % subsidiary of 2cureX A/S) in Hamburg, Germany. In parallel we have enabled the MicroCaT study site QEHB in the UK to perform IndiTreat® measurements. Second, 2cureX has established a Quality Management System (QMS) and performed and documented all experiments necessary for the CE-marking of IndiTreat®. 2cureX filed a Declaration of Conformity with the Danish Medicines Agency (Lægemiddelstyrelsen) in October 2018. It enables 2cureX to market IndiTreat® as a CE-IVD product under the Directive 98/79/EC for in vitro diagnostic medical devices. Third, the first part of the clinical validation of IndiTreat® is carried out in DK. This interventional trial is aimed at demonstrating the ability to generate tumoroids from liver metastasis biopsies and to perform IndiTreat® measurements guiding drug therapy in patients suffering from colorectal cancer. The interim analysis of this study revealed that both the primary and the secondary end-points have been met. Fourth, after the IPO at the Nasdaq First North stock exchange in Stockholm in November 2017, 2cureX has executed a very comprehensive dissemination and communication program comprising 30 Press Releases, 20 Non-scientific and non-peer reviewed publications, 7 Investor Presentations. 2cureX actively participated in 7 conferences. This has been flanked by social media activities on Twitter and LinkedIn. Finally, to prepare for market replication and commercialisation we have met and conducted interviews with target customers and added their input into a revised business plan. Together with reimbursement experts we have developed a market-access road map for Germany and put together a market access document package and are thus ready for a pre-launch of IndITreat®. Fifth, together with a consulting company specializing on market access we have reviewed the launch readiness of IndiTreat® and identified and closed gaps. Prior to the full commercialization 2cureX has started an early access program where IndiTreat® is provided to the patients of selected customers. These pre-commercialisation activities is conducted to establish logistics e.g. transportation of fresh tissue, defined treatment regimens, and reporting requirements for different European regions.
The valuable insights gained from IndiTreat® testing can be used i) during primary treatment to choose between multiple equivalent treatment options, ii) if the patient is not responding to a chosen treatment or iii) if the cancer recurs. The IndiTreat® variant for colorectal cancer now has a European CE-IVD approval. In addition to the clinical validation study performed within the MicroCaT project, 2cureX has started additional clinical studies with leading cancer hospitals in ovarian and pancreatic cancer. 2cureX is well on track with the MicroCaT objective to successfully operate a 2CX branch in Hamburg. With the CE-IVD marking of IndiTreat®, 2cureX made a very important step to market and develop IndiTreat® further in Europe. With strong clinical data, good dialogue with customers and patients, 2cureX is positioning IndiTreat® for launch in 2020. During the next couple of years 2cureX expects to become a key player in the area of functional precision medicine of several cancer entities in key European markets. To support this expansion, the company will grow both with regard to staff and business units. Most importantly, IndiTreat® will contribute to reducing cost and lost time associated with ineffective therapies and improve the quality of life of numerous European cancer patients.
IndiTreat(R) Features